This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed.

This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately one year after completing standard therapy. During this time, study participants will be followed closely by their doctor.

Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

Other Name: Sunitinib

Detailed Description:

This is a two-stage, phase II with historical controls, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population in comparison to historical controls. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The study population will consist of men and women with histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (e.g., papillary or follicular thyroid cancer) that has been previously treated with at least one course of radioactive iodine therapy and has evidence of residual, recurrent or progressive disease documented by any combination of radiologic studies and thyroglobulin levels.

To be eligible for inclusion, patients must fulfill each of the following criteria:

Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

a. If a patient has distant metastases, it must be documented by any combination of radiographic studies or whole body radioiodine scanning.

Previously treated with at least one course of radioactive iodine (I-131) therapy.

At least one measurable site of disease as defined by the Tumor Assessment Criteria in Appendix 3.

Serum thyroglobulin levels inappropriately elevated:

> 60 ng/mL with thyroid gland > 1 ng/mL without thyroid gland

ECOG performance status 0-2.

Life expectancy ≥ 3 months.

Normal organ function. The definitions of minimum adequacy for organ function required prior to study entry are as follows:

Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy.

Total serum bilirubin less than or equal to 1.5 x ULN.

Serum albumin greater than or equal to 3.0 g/dL.

Absolute neutrophil count (ANC) greater than or equal to 1500/uL.

Platelets greater than or equal to 100,000/uL.

Hemoglobin greater than or equal to 9.0 g/dL

Serum creatinine less than or equal to 1.5 x ULN.

Agreement to use contraceptives for women with child bearing potential. Unless surgically sterile, men must agree to use effective contraception during period of therapy.

The patient must be aware of the nature of his or her malignancy, understand the protocol requirements, risks, discomforts, and be able and willing to sign an informed consent.

Patients with a history of uncontrolled seizures, central nervous system disorders of psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from study.

Inability to swallow whole tablets.

Unwillingness to participate or inability to comply with the protocol for the duration of the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668811